A Study of Low Dose Interferon Alpha Versus Hydroxyurea in Treatment of Chronic Myeloid Neoplasms (DALIAH)
Polycythemia Vera, Essential Thrombocythemia, Primary Myelofibrosis
About this trial
This is an interventional treatment trial for Polycythemia Vera
Eligibility Criteria
Inclusion Criteria:
- Male or female > 18 years of age
- Newly diagnosed, or previously diagnosed untreated patients with ET, PV or PMF including prefibrotic myelofibrosis according to the WHO classification
- Active disease defined by one of the following criteria:
- need for phlebotomy
- leukocytosis > 10 mia/l
- thrombocytosis > 400 mia/l
- constitutional symptoms (fatigue, weight loss, night sweats or fewer > 38 degrees celsius)
- Pruritus
- splenomegaly causing symptoms
- previous thrombosis
Exclusion Criteria:
- Fertile women without a negative pregnancy test
- Other malignant disease within last 5 years
- ECOG performance score >/= 3
- Creatinine > 2x ULN
- Bilirubin > 1.5x ULN
- ALAT > 3x ULN
- Previous psychiatric disorder (depression)
- active autoimmune disease
- Uncontrolled thyroid disease
Sites / Locations
- Dept of Hematology, Aalborg hospital
- Dept. of Hematology, Aarhus University Hospital
- Dept of Hematology, Esbjerg Hospital
- Dept of Hematology, Herlev Hospital
- Dept of Hematology, Holstebro Hospital
- Dept of Hematology, Rigshospitalet
- Dept of hematology, Odense University Hospital
- Dept. of Hematology, Roskilde Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
PegIntron <= 60 years
Pegasys <= 60 years
PegIntron > 60 years
Pegasys > 60 years
Hydroxyurea > 60 years
In patients <= 60 years PegIntron is started at low-dose 35 micrograms once weekly. Dose escalation to 50 micrograms weekly if lack of complete hematological response at 4 months or lack of at least partial molecular response at 8 months. If complete hematological response or lack of at least partial molecular response is not achieved at 50 micrograms weekly at 12 months and 18 months respectively, dose escalation to 96 micrograms weekly.
In patients <= 60 years Pegasys is started at low-dose 45 micrograms once weekly. Dose escalation to 90 micrograms weekly if lack of complete hematological response at 4 months or lack of at least partial molecular response at 8 months. If complete hematological response or lack of at least partial molecular response is not achieved at 90 micrograms weekly at 12 months and 18 months respectively, dose escalation to 135 micrograms weekly.
In patients < 60 years PegIntron is started at low-dose 35 micrograms once weekly. Dose escalation to 50 micrograms weekly if lack of complete hematological response at 4 months or lack of at least partial molecular response at 8 months. If complete hematological response or lack of at least partial molecular response is not achieved at 50 micrograms weekly at 12 months and 18 months respectively, dose escalation to 96 micrograms weekly.
In patients > 60 years Pegasys is started at low-dose 45 micrograms once weekly. Dose escalation to 90 micrograms weekly if lack of complete hematological response at 4 months or lack of at least partial molecular response at 8 months. If complete hematological response or lack of at least partial molecular response is not achieved at 90 micrograms weekly at 12 months and 18 months respectively, dose escalation to 135 micrograms weekly.
Capsule Hydrea 500-2000 mg orally QD or BID